Study on Encorafenib and Binimetinib for People with BRAF V600 Mutated Hairy Cell Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04324112

Provider View

This clinical trial is testing a new combination of drugs, encorafenib and binimetinib, to see if they are more effective than vemurafenib in treating people with a specific type of hairy cell leukemia (HCL) that has a BRAF mutation and has not responded to or has returned after treatment.

Patient Parameters

Program Overview

Hairy cell leukemia (HCL) is a type of blood cancer that often doesn't respond well to chemotherapy. Most people with HCL have a mutation in the BRAF gene, which can make cancer cells grow faster. This study is testing whether a combination of two drugs, encorafenib and binimetinib, can work better than the drug vemurafenib in treating this type of leukemia. The study is open to adults aged 18 and older who have this BRAF mutation and whose cancer has not responded to or has come back after previous treatment.

Description

Hairy cell leukemia (HCL) is a rare type of blood cancer that makes up about 2% of all leukemia cases. While some treatments can lead to remission, they don't cure the disease, and patients often relapse. Most people with HCL have a mutation in the BRAF gene, which causes cancer cells to grow and survive. The drug vemurafenib has been used to treat this mutation, but its effects don't last long. A new combination of drugs, encorafenib and binimetinib, has shown promise in treating other cancers with the same mutation and may be more effective for HCL.

This study aims to see if this new combination can lead to better outcomes for people with BRAF-mutated HCL. Participants will take the study drugs in 28-day cycles, with encorafenib taken once daily and binimetinib taken twice daily. They will keep a diary of their medication and monitor their temperature daily. Regular visits will include tests and evaluations to monitor their health and the treatment's effects. Participants can continue treatment as long as it is effective and side effects are manageable. After treatment ends, follow-up visits will occur to monitor long-term health.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of hairy cell leukemia (HCL) with a BRAF V600 mutation.
  • Must have previously received treatment with a purine analog and need further treatment due to low blood counts, enlarged spleen, or other symptoms.
  • Must be 18 years or older.
  • Must not have any uncontrolled infections or other serious health issues.
  • Must not have received chemotherapy, immunotherapy, or other investigational treatments within four weeks before starting the study.
  • Must be able to understand and sign a consent form to participate in the study.
  • Must agree to use effective contraception during the study and for a period after the study ends.

Exclusion Criteria

  • Cannot have received chemotherapy, immunotherapy, or other investigational treatments within four weeks before starting the study.
  • Cannot have previously been treated with encorafenib or binimetinib.
  • Cannot be taking other investigational drugs or have had major surgery within six weeks before starting the study.
  • Cannot have allergies to the study drugs or their ingredients.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled health conditions, such as infections or heart problems.
  • Cannot have active hepatitis B or C infections.
  • Cannot have another active cancer requiring treatment.
  • Cannot have a history of bone marrow or stem cell transplant.
  • Cannot have significant heart or gastrointestinal issues that could affect the study drugs.

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